HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2— 510(k) K961463

Substantially Equivalent

Heartport, Inc.

FDA 510(k) clearance K961463 for HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2, Substantially Equivalent on 1996-10-08. Applicant: Heartport, Inc..

Clearance details

Applicant: Heartport, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1996-04-17
Decision date: 1996-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.